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A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems

Healthy Clinical Trial

Official title:
Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 685509 Over 28 Days in Patients With Mild and Moderate Hepatic Impairment and of Single Oral BI 685509 Dose Compared to Healthy Volunteers

Clinical Trial Summary

The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment [Child-Turcotte-Pugh (CTP) classification A and B] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03842761
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 1
Start date March 6, 2019
Completion date May 20, 2021
View Details
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